Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears

Andrews Research & Education Foundation

Status and phase: Completed; Phase 2

Conditions: Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture

Treatments: Drug: Experimental Group; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04088227

ACL-PRP Study

Details and patient eligibility

About

A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. Current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis.

The main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. We hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.

Full description

A non-surgical treatment option for the management of osteoarthritis include injectables such as corticosteroids and platelet rich plasma. These injectables work by positively affecting cartilage cells, also known as chondrocytes, and the cells of the joint lining tissue, also known as synoviocytes. Platelet rich plasma is an autologous derived blood product, i.e. a joint injectable made from the patient's own blood at the time and location of injection with simple blood centrifugation. Studies in the bench-top laboratory setting have provided in-vitro evidence that platelet rich plasma decreases synoviocyte production of metallometal proteases, an inflammatory protein with negative effects on cartilage and decreases the effects of inflammatory proteins.

Enrollment: 24 patients

Sex: All

Ages: 14 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No history of previous traumatic ipsilateral knee injury
• Bone bruise visualized on MRI
• No clinical evidence of posterior cruciate ligament injury with no more than grade 1 medial or lateral collateral ligament injury

Exclusion criteria

• Patients without a palpable knee effusion
• An injury occurring more than 10 days before enrollment
• Previous ipsilateral knee surgery
• Intra-articular cortisone or platelet rich plasma injection into either knee within 3 months of injury
• Participation in another clinical drug trial within the 4 weeks before injury
• A history of any inflammatory disease or immune-comprised

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Control Group

Active Comparator group

Description:

The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).

Treatment:

Other: Control Group

Experimental Group

Experimental group

Description:

The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).

Treatment:

Drug: Experimental Group